Years Ahead in HIV Prevention Research: Time to Market

This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.

Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of March 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Cabotegravir Implementation

Implementation studies completed, ongoing, or planned for cabotegravir as of March 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Dapivirine Vaginal Ring Implementation

Ongoing and planned implementation studies for the dapivirine vaginal ring as of March 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Cabotegravir Volume

Allocation of non-commercial cabotegravir for PrEP supply in low- and middle-income countries, 2023-2026, as of March 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Dapivirine Vaginal Ring Volume

DVR supply available to low- and middle-income countries as of March 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Cabotegravir Regulatory Approval

Regulatory approvals and those pending for cabotegravir as of March 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Dapivirine Vaginal Ring Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of March 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Trials & Projects Halted by USAID Funding Suspension

The stop-work orders have disrupted USAID-supported HIV prevention research, halting critical investigations in vaccine and next-generation PrEP strategies.

The abrupt suspension of these trials also raises serious ethical concerns. Stopping trials mid-course undermines trust in research, jeopardizes community engagement, and abandons participants who volunteer their bodies for scientific discovery. It will take years to build back this critical infrastructure—for HIV research and beyond—as well as the community partnership and trust needed to ensure smooth and ethical research.

Where We Are Now with LEN for PrEP

The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.

In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain.